FDA Approves Tavapadon for Adults With Parkinson Disease
Key Clinical Summary
- The FDA approved JUVMO (tavapadon) for adults with Parkinson disease, with availability for US patients expected in October 2026.
- Phase 3 TEMPO trials demonstrated improvements in activities of daily living and motor outcomes in early Parkinson disease and increased “on” time without troublesome dyskinesia when tavapadon was added to oral levodopa.
- Common adverse events varied by treatment setting and included nausea, headache, dizziness, dyskinesia, hallucinations, and orthostatic hypotension.
The US Food and Drug Administration (FDA) has approved tavapadon (JUVMO) tablets for the treatment of Parkinson disease in adults, announced manufacturer AbbVie. The drug is the first selective D1/D5 receptor agonist approved for this patient population.
Phase 3 Evidence
The approval is supported by data from the phase 3 TEMPO program, which evaluated tavapadon in patients with early Parkinson disease who were not receiving oral levodopa and as adjunctive therapy in patients receiving oral levodopa who experienced motor fluctuations.
In TEMPO-1, tavapadon significantly improved Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II scores, measuring activities of daily living, at week 26 compared with placebo. Scores changed by +0.9 with placebo compared with −1.6 with tavapadon 5 mg and −1.7 with 15 mg (P < .0001 for both comparisons).
Combined MDS-UPDRS Part II and III scores also significantly improved with both tavapadon doses compared with placebo (−9.7 and −10.2 vs +1.8, respectively; P < .0001 for both). TEMPO-2 similarly demonstrated significant improvements in MDS-UPDRS Part II and combined Part II and III scores at week 26.
In TEMPO-3, adjunctive tavapadon increased daily “on” time without troublesome dyskinesia by 1.10 hours compared with placebo (1.70 vs 0.60 hours; 95% CI, 0.60–1.70; P < .001).
Sustained efficacy was observed through 85 weeks in the TEMPO-4 open-label extension. Among participants receiving tavapadon plus levodopa, 93% did not increase their levodopa dose; among those receiving tavapadon without levodopa, 94% did not initiate levodopa.
Most treatment-emergent adverse events in the TEMPO program were nonserious and mild or moderate. Common events with tavapadon without levodopa included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. With concomitant levodopa, common events included nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.
Clinical Implications
Maintaining control of motor symptoms becomes increasingly difficult as Parkinson disease progresses and may require higher and more frequent doses of oral levodopa over time. While dopamine agonists have traditionally been used to further manage these symptoms and reduce the need for levodopa dose escalation, currently available agents primarily target D2/D3 receptors and may be limited by tolerability concerns.
"Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs,” said Hubert Fernandez, MD, professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator, in a news release.
Expected Availability
Tavapadon will be available as 5-, 10-, and 15-mg tablets, with 0.25- and 1-mg tablets contained in a titration pack. US availability is expected in October 2026, according to the manufacturer.
